(30 days)
The Cardioblate™ Gemini™ Surgical Ablation Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.
The Cardioblate Gemini surgical ablation device (Model 49351), figure 1 below, is a handheld, single-use, bipolar, radio-frequency (RF) ablation device for use in cardiac surgery. It has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode to cool the tissue during RF energy delivery. This device is intended for intermittent operation.
Model 49260 of the Cardioblate Gemini surgical ablation device is intended for use with Cardioblate 68000 Generator (figure 2), whereas Model 49351 is intended for use with the Valleylab™ FT10 Energy(figure 3), whereas model 49260 is intended for use with Cardioblate 68000 Generator(figure 3). The devices are provided sterile and nonpyrogenic, are disposable, and are for single use only. They are sterilized using ethylene oxide.
The Cardioblate Gemini-s is a bipolar electrode device that transmits radio frequency energy, generated by an external generator, between the two electrodes. The device has dual linear electrodes, 6.3 cm in length, with integral fluid delivery to the electrodes. The Gemini-s device is port accessible, intended for open or closed chest procedures to ablate tissue through resistive heating due to radiofrequency energy passing through tissue. The device is designed to reproduce the Cox-Maze lesion pattern by creating linear transmural lesions in both atria of the heart during cardiac procedures.
The Gemini-s surgical ablation device has a flexible neck design that provides the physician with the ability to access various anatomies utilizing a neck curve through the full range from 0 to 180-degree configuration.
Once the electrodes are correctly positioned, the parallel jaws lock by squeezing the handle. The electrodes have full contact with the tissue and the locking mechanism must be fully engaged to ensure accurate transmurality readings. Simultaneous with the actuation of the trigger and jaw closure is the opening of the (normally closed) fluid path to start the flow of saline. The device automatically shuts off the saline when the jaws are open and when the device is not in use.
The provided document is a 510(k) summary for the Medtronic Cardioblate Gemini-s 49260 and 49351 Surgical Ablation Devices. It states that the submission is a "Special 510(k) Notification" and that modifications were verified through "design verification testing." It also indicates that the "DFMECA file was updated along with the Risk Management File to reflect the current status and risk evaluations at the device and system level."
However, the document does not describe specific acceptance criteria and the study that proves the device meets those criteria, nor does it provide the detailed information requested in points 1-9 of your prompt.
The document focuses on demonstrating substantial equivalence to predicate devices (K121767 and K200514) based on having the same:
- intended use/indications for use
- contraindications
- operating principle
- energy type
- mechanism of action
- radiofrequency generator and delivery system
- patient contacting materials
- shelf life
- sterilization process
- dimensions
- performance
- irrigation
- electrical characteristics
- packaging configuration and materials
The only changes mentioned are "IFU updates (new warning and updated directions for use)." The document concludes that these changes "do not arise from different technological characteristics of the devices or raise different questions of safety and effectiveness."
Therefore, based solely on the provided text:
No information is available regarding specific acceptance criteria, reported device performance data, study design details (sample size, data provenance, expert involvement, adjudication), comparative effectiveness studies (MRMC), standalone performance, or training set details as requested. The document refers to "design verification testing" broadly, but does not provide any specifics about these tests, the criteria used, or the results obtained.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.